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MotionLoc Study, Femur Fractures

NCT01612208 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2

Last updated 2014-05-23

No results posted yet for this study

Summary

The objective of this study is to document callus formation and healing of fractures stabilized with locking plates utilizing modern MotionLoc screws that provide controlled axial micro-motion to actively promote fracture healing.

Conditions

  • Fracture of the Distal Femur

Interventions

DEVICE

Periarticular Locking Plate (NCB, Zimmer)

The proximal plate segment will be applied to the diaphysis using four 5.0 mm MotionLoc screws. The plate will not be compressed onto the femoral diaphysis to preserve periosteal perfusion and to enable controlled motion between the plate and the diaphysis. If desirable, temporary spacers of the NCB set may be used in the proximal plate segment to facilitate 1-2 mm plate elevation over the diaphysis. Only MotionLoc screws will be used for fixation of the NCB plate proximal to the fracture site.

DEVICE

MotionLoc Screw

The NCB Polyaxial Locking Plate System is indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones. These MotionLoc screws have a reduced 3.4 mm diameter mid-shaft section to bypass the near cortex. By avoiding rigid constraint in the near cortex, the MotionLoc screw design increases the working length of the screw, allowing for elastic flexion of the screw shaft within a controlled motion envelope in the near cortex.

Sponsors & Collaborators

Principal Investigators

  • Erik Kubiak · Orthopedic Surgery Operations

Eligibility

Min Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2012-05-31
Completion
2013-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01612208 on ClinicalTrials.gov